FDA approves second weight loss medication this year

Coverage of the FDA’s approval of Vivus’ Qsymia (phentermine/topiramate) was extensive with a focus on adding to the options available to physicians and patients for treating obesity. All stories noted previous problems with weight loss medications and the FDA’s previous rejection of it, as well as the other weight loss medication approved earlier this year. Stories also mentioned dangers of birth defects and worries about heart attacks.

ABC World News reported, “A big headline for the millions of Americans battling obesity tonight. … We’re awaiting word from the FDA, expected to approve a powerful new diet drug.” ABC added, “This is the first thing we’ve had to offer people in ten years between Weight Watchers and surgery.” Diane Sawyer noted that risks can include “memory loss, confusion, increased heart rate and birth defects.”

The New York Times reports, “The Food and Drug Administration approved a second new weight-loss drug, expanding the range of medical options for the one-third of American adults who are obese. The drug…offered the greatest weight loss in clinical trials of the three diet drugs that have been considered by the F.D.A. in recent years. But it also raises the risk of birth defects if used by pregnant women and can cause elevated heart rates and cognitive problems.”

The story explains that Qsymia, along with Arena’s Belviq (lorcaserin) and Contrave (bupropion/naltrexone) were all rejected by the FDA earlier for safety reasons, but that the first two have now been approved based on new data. The third may also be approved after a new trial.

The Wall Street Journal reports the approval in the context of growing obesity rates among Americans and explains that clinical studies on which it was based involved about 3,700 patients.

USA Today reports the medication “is expected to help heavy patients drop about 10% of their weight – more than any other approved obesity medication.” But “some experts are concerned that the drug raised the heart rates slightly in some patients.”

By comparison, lorcaserin “helps people lose about 5% or more of their starting weight.”

The story quotes Public Citizen’s Sidney Wolfe calling the FDA “reckless” for approving the medication, adding, “It’s either magical or delusional thinking to believe that a drug will turn off hunger without hitting other targets where it will do harm, which is usually the cardiovascular system.”

The AP says that “many doctors consider [it] the most effective therapy in a new generation of anti-obesity pills designed to help patients safely shed pounds.” But it “is not exactly a scientific breakthrough,” as it is “actually a combination of two older drugs that have long been known to help with weight loss.”

This entry was posted in General Health. Bookmark the permalink.